White Paper | IVBE Particle Characterisation of Generic Mometasone Furoate Using MDRS and Laser Diffraction

New IVBE Approaches for Generic Nasal Suspension Products 

Since early 2016 there has been significant focus from the generic pharmaceutical industry in pursuing an in-vitro only approach to bioequivalence (IVBE) for ANDA submissions to the FDA for nasal spray products. This new approach has been triggered by the successful approval of a generic Nasonex® by Apotex Corp, demonstrating Q1/Q2/Q3 equivalence and thus provided a weight of evidence approach that bypassed the traditional in-vivo clinical endpoint study requirement. The principle new technique used was the inclusion of a novel in-vitro method that utilised Morphologically- Directed Raman Spectroscopy (MDRS) technology to chemically identify and characterise the particle size distribution of the API particles within the nasal spray formulation.

In this paper, Ethan Dixon-Naish, Senior Analytical Chemist, describes the possibilities of this approach to assess and characterise API particle sizes following identification from the formulation excipients, and the use of orthogonal methodologies to assess API particles in the size range of <3μm, enabling more detailed comparison of the key particle size metrics for test and reference products.

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